{"effective_time":"20241211","id":"9fca8024-ba10-4ec1-82a2-0122533bcd8d","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label Seqirus Influenza A (H5N8) Monovalent Vaccine, Adjuvanted Rx Only One dose of 0.5 mL For IM Use For 6 months of age and older For use under EUA PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label","PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton NDC 70461-750-03 Rx Only Seqirus Influenza A (H5N8) Monovalent Vaccine, Adjuvanted For use under Emergency Use Authorization For Intramuscular Use For 6 months of age and older Ten single-dose pre-filled syringes. A single dose is 0.5 mL. Seqirus™ PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton","PRINCIPAL DISPLAY PANEL - 5 mL Vial Label NDC 70461-850-41 Seqirus Influenza A (H5N8) Monovalent Vaccine, Adjuvanted Rx Only For Intramuscular Use For 6 months of age and older. For use under Emergency Use Authorization Vial contains 10 doses of 0.5 mL. PRINCIPAL DISPLAY PANEL - 5 mL Vial Label","PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton NDC 70461-850-40 Rx Only Seqirus Influenza A (H5N8) Monovalent Vaccine, Adjuvanted For use under Emergency Use Authorization Twenty-five multi-dose vials. Ten doses per vial. A single dose is 0.5 mL. For Intramuscular Use. For 6 months of age and older. Shake gently before use. Each 0.5 mL dose contains 7.5 mcg of hemagglutinin of A/Astrakhan/3212/2020 IDCDC-RG71A SeqHS_SyS22_09.5A and MF59C.1 Adjuvant, an oil-in-water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate. Prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells. Each dose contains the preservative thimerosal at 50 mcg/0.5 mL dose (25 mcg mercury/dose). Manufactured by Seqirus Inc. Holly Springs, NC 27540, USA. Distributed by Seqirus USA Inc. 25 Deforest Avenue, Summit, NJ 07901, USA. 1-855-358-8966 Seqirus™ PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton"],"set_id":"e108a9fd-dda4-41b8-af1b-8892535c659d","spl_patient_package_insert":["FOR 6 MONTHS OF AGE AND OLDER You are being offered, SEQIRUS INFLUENZA A (H5N8) MONOVALENT VACCINE, ADJUVANTED, hereafter referred to as, SEQIRUS H5N8 VACCINE to prevent avian influenza virus (H5) infection. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized SEQIRUS H5N8 VACCINE for use in individuals 6 months of age and older. The FDA approved SEQIRUS H5N8 VACCINE for use under the EMERGENCY USE AUTHORIZATION (EUA) for individuals 6 months of age and older. For more information on EUA, see the \" What is an Emergency Use Authorization (EUA)? \" section at the end of this Fact Sheet. SEQIRUS H5N8 VACCINE has received EUA from FDA to provide: A 2-dose vaccination series administered 21 days apart in individuals 6 months of age and older. This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of SEQIRUS H5N8 VACCINE, which you may receive because H5 influenza viruses, which have been circulating in bird populations globally, have also been detected in mammals on farms and in the wild, including several human infections. Talk to your vaccination provider if you have questions. SEQIRUS H5N8 VACCINE may not protect everyone. WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE WHAT IS H5 INFLUENZA? H5 Influenza, also known as, \"Avian Influenza\" or \"Bird Flu,\" is caused by the H5 subtype influenza virus. Typically, H5 influenza only infects birds and occasionally other animals. However, it is also possible for humans to get H5 influenza after close contact with an animal that has the virus. It is predominantly a respiratory illness with similar symptoms as the seasonal flu. People with H5 influenza have had a wide range of symptoms reported, ranging from mild symptoms to severe illness, including death. Symptoms may include cough, sore throat, runny or stuff nose, conjunctivitis (red eyes), muscle or body aches, headaches, fatigue and shortness of breath or difficulty breathing and fever. Less common symptoms include diarrhea, nausea, vomiting, or seizures. WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THIS VACCINE? Tell your vaccination provider about all of your medical conditions, including if you: have any allergies have a fever have a bleeding disorder or are on a blood thinner are immunocompromised or are on a medicine that affects your immune system are pregnant or plan to become pregnant are breastfeeding have ever fainted in association with an injection WHO SHOULD NOT GET SEQIRUS H5N8 VACCINE? You should not get this vaccine if you: had a severe allergic reaction after a previous dose of influenza vaccine had a severe allergic reaction to any ingredient in these vaccines WHAT ARE THE INGREDIENTS IN THIS VACCINE? SEQIRUS H5N8 VACCINE contains, hemagglutinin (HA) protein of the H5 influenza virus strain and the MF59C.1 adjuvant (an ingredient designed to improve immune responses to the protein in a vaccine), which is composed of squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate and citric acid. Other ingredients consist of sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate, beta-propiolactone, cetyltrimethylammonium bromide, polysorbate 80 as well as residual amounts of protein other than HA, including Madin Darby Canine Kidney (MDCK) cell protein and MDCK cell DNA, which are used in the manufacturing process. The multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. HOW ARE THESE VACCINES GIVEN? SEQIRUS H5N8 VACCINE will be given to you as an injection into the muscle. The vaccine will be administered as a two-dose series, 21 days apart. HAVE THESE VACCINES BEEN USED BEFORE? In clinical trials, approximately 5977 individuals 6 months of age and older have received at least one dose of a similar vaccine, AUDENZ, which has been approved by the FDA for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype since 2020. SEQIRUS H5N8 VACCINE is made by the same process and has the same composition, except for the virus strain, as AUDENZ. WHAT ARE THE BENEFITS OF THESE VACCINES? Based on data from use of AUDENZ, SEQIRUS H5N8 VACCINE, is expected to provide protection against disease caused by the H5 influenza viruses. WHAT ARE THE RISKS OF THIS VACCINE ? There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: Difficulty breathing Swelling of your face and throat A fast heartbeat A bad rash all over your body Dizziness and weakness Side effects that have been reported in clinical trials with AUDENZ include: Injection site reactions: pain, redness, swelling (hardness) and bruising General side effects: fatigue, headache, generally feeling unwell (malaise), muscle pain, joint pain, nausea, loss of appetite, chills and fever Side effects that have been reported during post-authorization use of seasonal influenza vaccines that contain the same adjuvant or share the same manufacturing process include: Allergic reactions including severe reactions (anaphylaxis) Swollen lymph nodes (lymphadenopathy) Nervous system disorders, including sudden weakness of muscles on one side of the face (Bell's palsy), convulsions (including febrile convulsions), reduction of the protective covering of nerves (demyelination), swelling of the spinal cord and brain (encephalomyelitis), an autoimmune disease affecting the nervous system that can lead to temporary paralysis (Guillain-Barre syndrome), inflammation of the nerves (neuritis), tingling or numbness along the nerves (paresthesia) Fainting in association with injection of the vaccine (syncope) These may not be all the possible side effects of these vaccines. Serious and unexpected side effects may occur. WHAT SHOULD I DO ABOUT SIDE EFFECTS? If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS) . The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html . In addition, you can report side effects to Seqirus, Inc. at 1-855-358-8966 or via email at us.medicalinformation@seqirus.com. WHAT IF I DECIDE NOT TO GET SEQIRUS H5N8 VACCINE? Under the EUA, it is your choice to receive or not receive any of these vaccines. Should you decide not to receive any of these vaccines, it will not change your standard medical care. CAN I RECEIVE SEQIRUS H5N8 VACCINE AT THE SAME TIME AS OTHER VACCINES? Data have not been submitted to FDA on administration of SEQIRUS H5N8 VACCINE at the same time as other vaccines. If you are considering receiving SEQIRUS H5N8 VACCINE with other vaccines, discuss your options with your healthcare provider. WHAT IF I AM IMMUNOCOMPROMISED? If you are immunocompromised, you may have a reduced response to the vaccine. Vaccinations may not provide full immunity in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent H5 influenza. WHAT IF I AM PREGNANT OR BREASTFEEDING? If you are pregnant or breastfeeding, discuss your options with your healthcare provider. WILL THESE VACCINES GIVE ME H5 INFLUENZA? No. These vaccines do not contain any live virus and cannot give you H5 influenza. HOW CAN I LEARN MORE? Ask the vaccination provider Visit CDC at https://www.cdc.gov/ Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal- regulatory-and-policy-framework/emergency-use-authorization Contact your state or local public health department WHERE WILL MY VACCINATION INFORMATION BE RECORDED? The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. For more information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html . CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THIS VACCINE? No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a SEQIRUS H5N8 VACCINE. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients). WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427. WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current H5 influenza outbreak. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA approved product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent H5 influenza and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used. An EUA is in effect for the duration of the H5 influenza EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). Seqirus, Inc. 475 Green Oaks Parkway, Holly Springs, NC 27540, U.S.A Document Date: 05/22/2024"],"spl_patient_package_insert_table":["
FOR 6 MONTHS OF AGE AND OLDER
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